Intrauterine Levonorgestrel Device in Patients with Endometriosis

Completed

• Conditions: Clinically symptoms of endometriosis; dysmenorrhea; dyspareunia; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12614000015640
• Lead Sponsor: Istanbul Medeniyet University Goztepe Education and Research Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

All women have endometriosis symptoms. All of the women had regular menstrual periods (25–35 day intervals) for at least 6 months before particapting in the study, had not used any hormonal therapy for at least 6 months prior to the study. None of the women had been breastfeeding or had a desire to conceive in the ensuing 12 months. They had no history of osteoporosis, coagulation disorders, or contraindications to LNG-IUS.

Exclusion Criteria

The exclusion criteria included non-diagnosed vaginal bleeding, gynecological cancer history, chronical diseases such as liver pathologies or diabetes mellitus, pelvic inflammatory disease, septic abortion history in the last 3 months, malignancy doubt in biopsies, fertility desire, the uterus size bigger than 10 weeks of gestational age, submucosal leiomyoma or polyp, having a diagnosis of a gynecologycal pathology other than endometriosis and a history of hormonal medication usage in the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure improvements in severity and frequency of pain. Each patient was asked to complete questioannaries of SF-36 and visual analogue scales (VAS) in the first visit and 3rd, 6th, 9th and 12th months of the study. These scales recorded the non-cyclic pain, dysmenorrhoea, severity of dyspareunia symptoms effects on life quality and degree of satisfaction after treatment. [The patients were assessed physically, sonographically and mentally at the beginning of the study and then periodically after the first visit at the 3rd, 6th, 9th and 12th months of the study.]

Secondary Outcome Measures

Name	Time	Method
Serum CA-125 levels were measured in the plasma samples of each participant by the laborotory. Changes in the Ca-125 levels were noted accordingly.[patients assessed every 3 months for a total of 12 months period.];The menstrual symptoms such as noncyclic bleeding, menorrhagia, acnes, mood swings were each evaluated by patient questionnaires in each visit.[The participants were assessed every 3 months for a total of 12 months period.]